Effects of Progressive Resistance Training Vasomotor Symptoms in Post Menopausal Women

Not Applicable

Recruiting

• Conditions: Post Menopausal
• Interventions: Other: Progressive resistance training; Other: Control group

• Registration Number: NCT06166264
• Lead Sponsor: Riphah International University

Brief Summary

The study will be a randomized clinical trial and will be conducted in Civil Hospital and Kalsoom Hospital Samundry. This study will be completed in time duration of 10 months after the approval of synopsis. Non probability convenience sampling with Randomization technique will be used and 26 participants will be recruited in study after randomization. The subjects will be divided into two groups and the group A will receive Progressive training and Health education and group B will receive only Health education. The data will be assessed at the baseline and after 8th week of treatment. After data collection data will be analyzed by using SPSS version 21.

Detailed Description

The significance of this study is that it may improve the postmenopausal symptoms like depression and vasomotor symptoms which includes hot flushes , night sweats etc .in postmenopausal females. The majority of studies examining the vasomotor symptoms affected by symptoms of post menopause have concentrated on the effects of therapies like hormone therapy.To our knowledge, no studies have looked at the connection between vasomotor symptoms,depression and resistance training. Without doing so, it is challenging to understand how Vasomotor symptoms have an impact. This study sought to fill in the knowledge vaccum by examining the resistance training effect on depression , fatigue and vasomotor symptoms.

Study Timeline

• Study Start: 2023-04-05
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

Post-menopausal women with age 50 - 60 years Blood pressure less than 160 / 100 More than or equal to 4 moderate-severe vasomotor symptoms including hot flushes, nocturnal sweats, sweating and poor sleep.

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Exclusion Criteria

Chronic metabolic and endocrine diseases Receiving hormone replacement treatment Surgical menopause Cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progressive resistance training	Progressive resistance training	-
Control group	Control group	-

Primary Outcome Measures

Name	Time	Method
FATIGUE SEVERITY SCALE	6th week	The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle.
Hot Flash related Interference Scale (HFRDIS) for vasomotor symptoms	6th week	The HFRDIS is a 10-item scale which measures the degree hot flashes interfere with daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was internally consistent, with alphas of 0.96 at times
DASS-21( Depression, Anxiety and stress scale 21-item	6th Week	DASS-21 is a self reported questionnaire which is used to assess the severity of range of symptoms like depression, anxiety and stress. It is not only used to measure the severity of symptoms but can also be used to assess the subject's response to treatment.The reliability of DASS-21 showed that it has excellent Cronbach's alpha values of 0.81,0.89 and 0.78 for the subscales of depressive, anxiety and stress respectively.

Trial Locations

Locations (1)

Civil Hospital Samundry; 🇵🇰 Samundry, Pakistan